Immupharma Share Discussion Threads

[ken chung] 24/5/2018 15:42

The Phase 3 trial primary end point was not met.

It failed.

Its a flop.

[ken chung] 24/5/2018 15:41

Going down.

[bookbroker] 24/5/2018 15:39

That’s it for you on ADVFN, you’ll be looking for a new bulletin board with those words of wisdom! IMM is screwed, and anyone stupid enough to be holding here deserves to lose their shirt!

[roundup] 24/5/2018 15:26

Langstor! you are well out of order, making a statement like that.

[obiterdicta] 24/5/2018 15:23

NG no I am not certain but the point I am making is you can't be certain that the FDA won't approve either.

You hang your hat on P value. But the world is more complex with that.

You still haven't engaged my Wednesbury irrational point.

Or do you accept for a public body to be successfully reviewed by the courts then the decision has to be irrational. In which case you have no basis to say that GSK would sue as irrationality is difficult to prove.

OD

[wigwammer] 24/5/2018 15:23

Langstor filtered

[wigwammer] 24/5/2018 15:23

He doesn't have to be certain. The market cap is sub £50m - if there is any meaningful chance it gets approved the risk/reward looks positive.

[nobbygnome] 24/5/2018 15:20

>> roundup

Believe me we are. However, it is not that simple to get a place in a good home. They would much rather have permanent residents. In the past we have booked respite well in advance for holidays etc but it is difficult short term.

[nobbygnome] 24/5/2018 15:19

Not for a drug with a p value of 0.28. What you are talking about refers to drugs which narrowly miss their significance on the primary endpoint (not post hoc analysis).

I note you are by no means certain that the FDA will approve the drug....

[obiterdicta] 24/5/2018 15:16

NG

You are still talking about rules based regulations. Regulation has moved on to principles based regulation. Keep up!

The principles are sufficiently flexible to be pretty much unreviewable unless Wednesbury irrational.

Why do you say any evidence based decision on FDA approval would be Wednesbury irrational?

Engage with this point otherwise you look evasive.

Thanks

OD

[nobbygnome] 24/5/2018 15:15

Which is not significant....

[che7win] 24/5/2018 15:13

Wigwammer,
Yes, he also said that he expects a sharp rise when IMM releases further data analysis, so why is he so surprised? He can see it happening.

Think he just wants to be always right or something.

That I guess is what's so annoying - he knows the drug works, and statistically so for this group of patients P=0.0967:

"Importantly, in patients who had anti-dsDNA autoantibodies (a recognised biomarker for Systemic Lupus Erythematosus ('SLE')), Lupuzor™ demonstrated a superior response rate over placebo (61.5% vs 47.3%, p = 0.0967"

[nobbygnome] 24/5/2018 15:12

Thanks wiggy.

I don't usually bother with ticks but gave you a 👍 On this occasion!

[wigwammer] 24/5/2018 15:03

I agree che, he seems rattled. I will apologise for misreading his post however.. "He had no idea why I was asking but unprompted said that the dosing level was 'too good to be true'. So I wasn't the only one to have grave concerns about the amount of drug which was being given. He went on to correctly predict that the phase III would be negative."

[nobbygnome] 24/5/2018 15:01

>> mcsquared

If the FDA approve a drug with a p value of 0.28 on the primary endpoint which was pre agreed, GSK and probably AZ and various other companies would sue them for breaking their own rules. Clearly GSK (and maybe AZ) will have a lot to lose commercially. It will happen. I have personal evidence of a company threatening to sue the FDA when they went against what they had said in a minuted meeting. The FDA capitulated because they knew they would lose.

[nobbygnome] 24/5/2018 14:57

So are you going to apologise for wrongly accusing me of plagurism?

[nobbygnome] 24/5/2018 14:56

>> wiggy

You just post misleading information. Benlysta met its primary endpoint with statistical significance. Admittedly it was the only time point where it was significant but that is why the FDA HAD to approve it. Perhaps you are getting the importance of statistical significance now for regulators...

I can't believe the rubbish which is posted as fact here.